Uterine therapy device and method

ABSTRACT

A method and system of providing therapy to a patient&#39;s uterus. The system has an access tool with a lumen, the access tool being adapted to be inserted through a human cervical canal to place an opening of the lumen within a uterus when the access tool is inserted through the cervical canal; a seal disposed at a distal region of the access tool and adapted to seal the access tool against an interior cervical os; a sealing indicator adapted to provide a user with an indication that the seal has sealed the access tool with the interior cervical os; and a vapor delivery mechanism adapted to deliver condensable vapor through the access tool to the uterus, the condensable vapor being adapted to condense within the uterus.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims the benefit under 35 U.S.C. §119 of U.S.Provisional Application No. 60/957,626, filed Aug. 23, 2007, thedisclosure of which is incorporated by reference as if fully set forthherein.

This application is related to U.S. application Ser. No. 12/197,084,filed Aug. 22, 2008, entitled “Uterine Therapy Device and Method”; andto U.S. application Ser. No. 12/197,096, filed Aug. 22, 2008, entitled“Uterine Therapy Device and Method”; and to U.S. application Ser. No.12/197,104, filed Aug. 22, 2008, entitled “Uterine Therapy Device andMethod”, all of which are commonly owned.

INCORPORATION BY REFERENCE

All publications and patent applications mentioned in this specificationare herein incorporated by reference to the same extent as if eachindividual publication or patent application was specifically andindividually indicated to be incorporated by reference.

BACKGROUND OF THE INVENTION

Endometrial ablation (i.e., the removal or destruction of theendometrial lining of the uterus) is used as an alternative tohysterectomy for treating menorrhagia, or other uterine diseases. Oneprior technique for performing endometrial ablation employ aresectoscope (i.e., a hysteroscope with a built-in wire loop or otherablative devices) that is inserted transcervically into the uterus, anduses radio-frequency electrical current (RF current) to remove orcoagulate the endometrial tissue. These standard techniques typicallyare performed in a hospital setting.

Some approaches make use of heated fluid to ablate the endometrium. Forexample, early journal articles describe the use of steam to treatuterine hemorrhage. See, e.g., Van de Velde, “Vapo-“Cauterization of theUterus,” Amer. J. Med. Sci., vol. CXVIII (1899); Blacker, “Vaporizationof the Uterus,” J. Obstet. & Gyn., pp. 488-511 (c. 1901). The use ofsteam for this purpose was later discredited, apparently due to patientmorbidity and mortality. See, e.g., Fuller U.S. Pat. No. 6,139,571. Morerecent descriptions of the use of injecting hot fluid into the uterusmay be found in Goldrath U.S. Pat. No. 5,451,208 and Evans et al. U.S.Pat. No. 5,540,658; U.S. Pat. No. 5,437,629.

Uterine therapies employing a contained fluid have also been described.See, e.g., Quint U.S. Pat. No. 5,084,044; Chin U.S. Pat. No. 5,449,380;Neuwirth et al., “The Endometrial Ablator: A New Instrument”, Obst. &Gyn., 1994, Vol. 83, No. 5, Part 1, pp 792-796. Another balloon-basedsystem using ultrasound as the energy source is described in U.S. Pat.No. 7,004,940.

High frequency, or radiofrequency (RF), energy has been used to performthermal ablation of endometrial tissue. See, e.g., Prior et al.,“Treatment of Mennorrhagia By Radiofrequency Heating”, Int. J.Hyperthermia, 1991 Vol. 7, No. 2, pp. 213-220; Stern et al. U.S. Pat.No. 5,443,470; U.S. Pat. No. 5,769,880; U.S. Pat. No. 6,929,642.

Current products for performing endometrial ablation include theNovaSure® procedure and a system marketed under the trade nameTHERMACHOICE®, by Ethicon, Inc. of Somerville, N.J.

Cryogenic ablation, or “cryoablation,” is another endometrial treatmentapproach. See, e.g., Droegemueller et al. U.S. Pat. No. 3,924,628; U.S.Pat. No. 6,306,129; and U.S. Pat. No. 7,101,367.

Finally, U.S. Pat. Appl. Publ. No. 2004/0068306 describes the use ofvapor, such as steam, for endometrial or other tissue ablation, and U.S.Pat. Appl. Publ. No. 2002/0177846 describes the use of vapor fortreating uterine fibroids.

SUMMARY OF THE INVENTION

One aspect of the invention provides a method of providing therapy to apatient's uterus. The method includes the steps of inserting an accesstool through a cervix and a cervical canal into the uterus; activelycooling the cervical canal; delivering vapor through the access toollumen into the uterus; and condensing the vapor on tissue within theuterus. In some embodiments, the step of actively cooling comprisingsupplying a flow of coolant through a coolant flowpath in the accesstool. The access tool may have an expandable member (such as, e.g., aballoon), in which case the coolant flowpath may be disposed within theexpandable member, and the expandable member may be expanded with thecoolant. The coolant flowpath may also have a coolant inletcommunicating with a coolant source and a coolant outlet communicatingwith an interior volume of the expandable member, in which case thesupplying step may include the step of supplying coolant flow from thecoolant inlet through the coolant outlet. The coolant flowpath may alsobe a coolant lumen formed in the access tool, in which case thesupplying step may include the step of supplying coolant flow from thecoolant inlet through the coolant lumen.

In some embodiments, the method also includes the step of sealing aninterior cervical os after the inserting step, e.g., by expanding anexpandable member such as a balloon. The expanding step may also includethe step of preferentially expanding a sealing portion of the balloondisposed at the interior cervical os prior to expanding an indicatorportion of the balloon disposed proximal to the interior cervical os.The balloon may be expanded with coolant.

Some embodiments of the invention include the step of placing anexpansion mechanism in contact with tissue within the uterus to moveuterine tissue away from an opening in the lumen. The method may alsoinclude the step of advancing the expansion mechanism distally prior tothe placing step.

In some embodiments, the step of delivering vapor includes the step ofinserting a vapor delivery tool through the access tool lumen. Themethod may also include the step of exhausting vapor and vaporcondensate from the uterus.

Another aspect of the invention provides a uterine heat therapy systemincluding: an access tool with a lumen, the access tool being adapted tobe inserted through a human cervical canal to place an opening of thelumen within a uterus when the access tool is inserted through thecervical canal; an active cooling mechanism adapted to cool the cervicalcanal, the active cooling mechanism having a coolant source; and a vapordelivery mechanism adapted to deliver condensable vapor through theaccess tool to the uterus, the condensable vapor being adapted tocondense within the uterus. The access tool may have further a coolantflowpath communicating with the coolant source. The access tool may alsohave an expandable member (such as a balloon), with the coolant flowpathbeing disposed within the expandable member. The coolant flowpath mayinclude a coolant inlet communicating with the coolant source and acoolant outlet communicating with an interior volume of the expandablemember. The coolant flowpath may also be a coolant lumen formed in theaccess tool.

In some embodiments, the system has a seal disposed at a distal regionof the access tool and adapted to seal against an interior cervical os.The seal may be, e.g., an expandable member, such as a balloon. Theballoon may have a distal sealing portion adapted to preferentiallyexpand prior to a proximal indicator portion when the balloon isexpanded with fluid.

Some embodiments of the system also have an expansion mechanism adaptedto contact tissue within the uterus to move uterine tissue away from theopening in the access tool lumen. Such a system may also have anadvancement mechanism operatively connected to the expansion mechanismto move the expansion mechanism distally with respect to the accesstool.

Some embodiments may also provide a vapor delivery tool adapted to beinserted through the access tool lumen.

Still another aspect of the invention provides a method of providingheat therapy to a patient's uterus. In some embodiments the methodincludes the steps of: inserting an access tool through a cervix and acervical canal into the uterus; placing an expansion mechanism incontact with tissue within the uterus to move uterine tissue surfacesaway from an opening in an access tool lumen; delivering vapor throughthe vapor delivery tool into the uterus; and condensing the vapor ontissue within the uterus.

In some embodiments, the method includes the step of advancing theexpansion mechanism distally prior to the placing step. In someembodiments the expansion mechanism may be advanced to place a distalportion of the advancement mechanism adjacent a fallopian os prior todelivering vapor, and in some embodiments advancement of the expansionmechanism will cease before a distal portion of the advancementmechanism reaches a fallopian os and prior to delivery of vapor.Advancement of the expansion mechanism may be performed by moving anexpansion mechanism actuator on the access tool.

In some embodiments the expansion mechanism may have two expansion arms,in which case the placing step may include the step of moving theexpansion arms apart. In some embodiments distal portions of theexpansion arms together form an obturator tip prior to the step ofmoving the expansion arms apart.

Some embodiments of the invention include the step of sealing aninterior cervical os after the inserting step. In some embodiments, thestep of delivering vapor includes the step of inserting a vapor deliverytool through the access tool lumen.

Yet another aspect of the invention provides a uterine heat therapysystem including: an access tool adapted to be inserted through a humancervical canal to place an opening of an access tool lumen within auterus when the access tool is inserted through the cervical canal; anexpansion mechanism adapted to be advanced into the uterus to moveuterine tissue surfaces away from the opening in the access tool lumen;and a vapor delivery mechanism adapted to deliver condensable vaporthrough the access tool to the uterus, the condensable vapor beingadapted to condense within the uterus.

In some embodiments, the expansion mechanism, when fully advanced, isadapted to extend beyond the opening of the access tool lumen less thana distance from an interior cervical os of the uterus to a fallopiantube os of the uterus. In other embodiments the expansion mechanism,when fully advanced, is adapted to extend beyond the opening of theaccess tool lumen substantially all a distance from an interior cervicalos of the uterus to a fallopian tube os of the uterus.

In some embodiments, the access tool includes an expansion mechanismactuator operatively connected to the expansion tool to expand theexpansion tool. The expansion mechanism actuator may also be furtheradapted to advance the expansion mechanism distally beyond the openingof the access tool lumen.

In some embodiments, the expansion mechanism includes two expansion armsadapted to move apart as the expansion mechanism is advanced beyond theopening of the access tool lumen. In some of these embodiments, distalportions of the expansion arms together form an obturator tip prior tomoving the expansion arms apart. In addition, each of the distalportions of the expansion arms is sized to substantially occlude afallopian os of the uterus.

Some embodiments also include a seal disposed at a distal region of theaccess tool and adapted to seal against an interior cervical os. Someembodiments of the system also include a vapor delivery tool adapted tobe inserted through the access tool lumen.

Still another aspect of the invention provides a method of providingheat therapy to a patient's uterus including the following steps:inserting an access tool through a cervix and a cervical canal into theuterus; after inserting the access tool into the uterus, inserting avapor delivery tool through an access tool lumen; delivering vaporthrough the vapor delivery tool into the uterus; and condensing thevapor on tissue within the uterus.

Some embodiments of the invention also include the step of connectingthe vapor delivery tool to a vapor source prior to the step of insertingthe vapor delivery tool through the access tool lumen. In some of thoseembodiments, the method also includes the step of passing vapor from thevapor source through at least a portion of the vapor delivery tool to anexhaust port exterior the patient prior to delivering vapor to theuterus. In embodiments in which the vapor delivery tool has a vapordelivery actuator operatively connected to the vapor source, the methodmay further include the step actuating the vapor delivery actuator priorto the step of delivering vapor.

In some embodiments, the delivering step includes the step of deliveringvapor through a plurality of exit ports in the vapor delivery tool, suchas through an exit port disposed at a distal tip of the vapor deliverytool and through an exit port on a longitudinal portion of the vapordelivery tool. The delivering step may also further include the step ofmoving a movable member disposed within a vapor delivery tool lumenadjacent at least one exit port to alter vapor flow through the at leastone exit port.

Some embodiments of the invention include the step of exhausting vaporand/or vapor condensate from the uterus, such as through a vapor exhaustchannel disposed radially outward from a vapor delivery channel; througha vapor exhaust channel disposed between an exterior surface of thevapor delivery tool and an interior surface of the access tool; and/orthrough a vapor exhaust channel disposed in the vapor delivery tool. Themethod may also include the step of sealing an interior cervical osafter the inserting step.

In some embodiments, the method includes the step of placing anexpansion mechanism in contact with tissue within the uterus to moveuterine tissue away from an opening in the lumen prior to the deliveringstep. The method may also include the step of advancing the expansionmechanism distally with respect to the access tool lumen prior to theplacing step.

Another aspect of the invention provides a uterine heat therapy systemincluding: an access tool, the access tool being adapted to be insertedthrough a human cervical canal to place an opening of the access toollumen within a uterus when the access tool is inserted through thecervical canal; and a vapor delivery mechanism, the vapor deliverymechanism having a vapor delivery tool and a vapor source, the vapordelivery tool being adapted to be inserted through the access tool todeliver condensable vapor from the vapor source to the uterus, thecondensable vapor being adapted to condense within the uterus.

Some embodiments of the vapor delivery tool have a vapor exit port, inwhich case the vapor delivery mechanism may further have a vapordelivery tool warming circuit with a vapor flow path from the vaporsource to a vapor exhaust without passing through the vapor deliverytool vapor exit port. In such embodiments, the vapor delivery mechanismmay also have a vapor delivery tool connector, with the vapor deliverymechanism being configured to deliver vapor through the warming circuitautomatically when the vapor delivery tool connector is connected to thevapor source. The vapor delivery mechanism may also have a vapordelivery actuator operatively connected to the vapor delivery tool andthe vapor source to control delivery of vapor from the vapor source to avapor delivery tool exit port and to direct vapor through the vapordelivery tool warming circuit.

Some embodiments of the vapor delivery tool have a plurality of vaporexit ports. In some of such embodiments, none of the vapor exit ports isat a distal tip of the vapor delivery tool. In some such embodiments,the plurality of exit ports include one or more exit ports on alongitudinal portion of the vapor delivery tool proximal to a distal tipof the vapor delivery tool. The vapor delivery tool may also include amovable member disposed within a vapor delivery tool lumen adjacent atleast one exit port, the movable member being adapted to alter vaporflow through the at least one exit port in response to vapor flowthrough the vapor delivery tool.

In some embodiments, the vapor delivery tool has a vapor deliverychannel, with the uterine heat therapy system further including a vaporexhaust channel adapted to exhaust vapor and/or condensed vapor from theuterus. The vapor delivery channel may be disposed radially inward fromthe vapor exhaust channel. In some embodiments, the vapor exhaustchannel may be disposed between an exterior surface of the vapordelivery tool and an interior surface of the access tool. In someembodiments, the vapor exhaust channel may be disposed in the vapordelivery tool.

In some embodiments, the vapor delivery tool has an exit port at adistal end of a vapor delivery channel and an atraumatic tip disposeddistal to the exit port. The vapor delivery tool may also have aflexible support (such as a coil) supporting the atraumatic tip. Theflexible support may surround the exit port and may have a vaporpassage.

In some embodiments, the vapor delivery tool has a vapor exhaust channeldisposed radially outward from the vapor delivery channel. The vaporexhaust channel may have an inlet disposed proximal to the vapordelivery channel exit port.

Some embodiments of the invention have a seal disposed at a distalregion of the access tool and adapted to seal against an interiorcervical os. Some embodiments also have an expansion mechanism adaptedto contact tissue within the uterus when the opening of the access toolis inserted into the uterus to move uterine tissue away from the openingin the access tool lumen.

Still another aspect of the invention provides a method of providingheat therapy to a patient's uterus, including the following steps:inserting an access tool through a cervix and a cervical canal into theuterus; after inserting the access tool into the uterus, creating a sealbetween an exterior surface of the access tool and an interior cervicalos; providing an indication to a user that the seal has been created;delivering vapor through the access tool lumen into the uterus; andcondensing the vapor on tissue within the uterus.

In some embodiments, the step of creating a seal comprises expanding anexpandable member, such as a balloon. The expanding step may include thestep of preferentially expanding a sealing portion of the balloondisposed at the interior cervical os prior to an indicator portion ofthe balloon disposed proximal to the interior cervical os. The expandingstep may also include the step of supplying coolant to the balloon.

In some embodiments, the method includes the step of placing anexpansion mechanism in contact with tissue within the uterus to moveuterine tissue away from an opening in the access tool lumen. Some suchembodiments include the step of advancing the expansion mechanismdistally with respect to the access tool lumen prior to the placingstep.

In some embodiments, the step of delivering vapor includes the step ofinserting a vapor delivery tool through the access tool lumen. Someembodiments also include the step of exhausting vapor and/or vaporcondensate from the uterus.

Yet another aspect of the invention provides a uterine heat therapysystem having: an access tool with a lumen, the access tool beingadapted to be inserted through a human cervical canal to place anopening of the lumen within a uterus when the access tool is insertedthrough the cervical canal; a seal disposed at a distal region of theaccess tool and adapted to seal the access tool against an interiorcervical os; a sealing indicator adapted to provide a user with anindication that the seal has sealed the access tool with the interiorcervical os; and a vapor delivery mechanism adapted to delivercondensable vapor through the access tool to the uterus, the condensablevapor being adapted to condense within the uterus.

In some embodiments, the seal includes an expandable member, such as aballoon. In some such embodiments, the balloon has a distal sealingportion adapted to preferentially expand prior to a proximal indicatorportion when the balloon is expanded with fluid.

Some embodiments also include an expansion mechanism adapted to contacttissue within the uterus to move uterine tissue away from the opening inthe access tool lumen. Some such embodiments also include an advancementmechanism operatively connected to the expansion mechanism to move theexpansion mechanism distally with respect to the access tool. Someembodiments also include a vapor delivery tool adapted to be insertedthrough the access tool lumen.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the invention are set forth with particularity inthe claims that follow. A better understanding of the features andadvantages of the present invention will be obtained by reference to thefollowing detailed description that sets forth illustrative embodiments,in which the principles of the invention are utilized, and theaccompanying drawings of which:

FIG. 1 is a partial cross-sectional drawing showing an embodiment of theinvention in place in a uterus.

FIGS. 2 and 3 are partial cross-sectional drawings showing theembodiment of FIG. 1 treating a uterus.

FIG. 4 is an elevational view of a vapor delivery tool according to oneembodiment of the invention along with a blow-up view of the tip of thevapor delivery tool.

FIG. 5 is an elevational view of a distal end of a vapor delivery toolaccording to another embodiment of the invention.

FIG. 6 is an elevational view of a distal end of a vapor delivery toolaccording to yet another embodiment of the invention.

FIG. 7 is an elevational view of a distal end of a vapor delivery toolaccording to still another embodiment of the invention.

FIG. 8A is an elevational view of a distal end of a vapor delivery toolaccording to another embodiment of the invention along with a blow-upcross-sectional view.

FIG. 8B is a cross-sectional view of a distal end of a vapor deliverytool according to yet another embodiment of the invention.

FIG. 9 is an elevational view of the vapor delivery tool of FIG. 8A or8B delivering vapor.

FIG. 10 is an elevational view of an expansion mechanism of a uterineaccess tool according to one embodiment of the invention.

FIG. 11 is a cross-sectional view along the line A-A of the embodimentof FIG. 10.

FIG. 12 is another elevational view of the expansion mechanism of FIG.10.

FIG. 13 is a cross-sectional view along the line B-B of the embodimentof FIG. 12.

FIG. 14 is a perspective view of the expansion mechanism of FIG. 10emerging from a delivery tool cannula.

FIG. 15 is a cross-sectional view of portions of the embodiment of FIG.10.

FIG. 16 is a cross-sectional view showing an expansion mechanism loadingtool according to one embodiment of the invention.

FIGS. 17 and 18 are elevational views of the expansion mechanism loadingtool of FIG. 16 in use.

FIG. 19 shows an expansion mechanism loaded into a uterine access toolaccording to one aspect of the invention.

FIG. 20A shows another embodiment of an expansion mechanism and uterineaccess tool.

FIG. 20B is a cross-sectional view of portions of the uterine accesstool of FIG. 20A.

FIG. 21A is an elevational view of an obturator of a uterine access toolaccording to one embodiment of the invention.

FIG. 21B is a cross-sectional view of the obturator of FIG. 21A.

FIG. 22 is an elevational view of portions of a uterine access tool.

FIG. 23 is a cross-sectional view of the uterine access tool of FIG. 22.

FIG. 24 is another elevational view of the access tool of FIG. 22.

FIG. 25 is a cross-sectional view of the access tool along the line A-Aof FIG. 24.

FIG. 26 is an elevational view of the access tool of FIG. 22 showing anobturator in place.

FIG. 27 is a cross-sectional view along the line B-B of FIG. 26.

FIG. 28 is a cross-sectional view of a uterine access tool according toan embodiment of the invention.

FIG. 29 is a cross-sectional view of a uterine access tool according toan embodiment of the invention.

FIG. 30 is a cross-sectional view of a uterine access tool according toan embodiment of the invention along the line B-B of FIG. 31.

FIG. 31 is a cross-sectional view of a uterine access tool according tothe embodiment of FIG. 30.

FIGS. 32-34 show cross-sectional views of alternative embodiments ofuterine access tools.

FIGS. 35 and 36 are elevational views of a uterine access tool accordingto yet another embodiment of the invention.

FIG. 37 shows the uterine access tool of FIGS. 35 and 36 in use with avapor delivery tool to treat a uterus.

FIG. 38 are side and end elevational views of a uterine access tool anda vapor delivery tool according to still another embodiment of theinvention.

FIG. 39 are side and end elevational views of the uterine access tooland vapor delivery tool of FIG. 38.

FIG. 40 is an elevational view of a uterine access tool according to yetanother embodiment of the invention.

FIG. 41 shows still another embodiment of a uterine access tool andvapor delivery tool.

FIG. 42 is a cross-sectional view along the line A-A of the embodimentof FIG. 41.

FIG. 43 is a cross-sectional view along the line B-B of the embodimentof FIG. 41.

FIG. 44 is a partial view of yet another embodiment of the invention.

FIG. 45 is a partial cross-sectional view of the embodiment of FIG. 44.

FIG. 46 is a perspective view of a uterine access tool and a vapordelivery tool according to still another embodiment of the invention.

FIG. 47 is a perspective view of the embodiment of FIG. 46 with thevapor delivery tool inserted into the uterine access tool.

FIG. 48 is a cross-sectional view of the uterine access tool of FIG. 46.

FIG. 49 is a cross-sectional view of the uterine access tool of FIG. 46.

FIG. 50 is another cross-sectional view of the uterine access tool ofFIG. 46.

FIG. 51 is a perspective view of a uterine access tool according toanother embodiment of the invention.

FIG. 52 is a cross-sectional view of the vapor delivery tool of FIG. 46.

FIG. 53A is an end elevational view of another uterine access toolembodiment.

FIG. 53B is a cross-sectional view of the uterine access tool of FIG.53A.

FIG. 54A is an end elevational view of the uterine access tool of FIG.53A showing the expansion mechanism partially advanced.

FIG. 54B is a cross-sectional view of the uterine access tool of FIG.53A showing the expansion mechanism partially advanced.

FIG. 55A is an end elevational view of the uterine access tool of FIG.53A showing the expansion mechanism fully advanced.

FIG. 55B is a cross-sectional view of the uterine access tool of FIG.53A showing the expansion mechanism fully advanced.

FIG. 56 is a perspective and partial cross-sectional view of a uterinetherapy system according to yet another embodiment of the invention.

DETAILED DESCRIPTION OF THE INVENTION

The present invention provides improved methods and apparatus forendometrial ablation using heated vapor.

FIGS. 1-45 show embodiments of a system 10 for heating and ablating theendometrium 12 of a uterus 14. In these embodiments, the system 10includes a vapor delivery component or tool 16, a uterus expansionmechanism, such as basket 18, and an access tool or introducer 20. Asshown in FIGS. 1-3, basket 18 and the distal end of the vapor deliverycomponent 16 have been inserted through the cervical os 22 and cervicalcanal 24 into the lumen or cavity 25 of the uterus. Basket 18 has beenexpanded after insertion to open up the uterine cavity and to keeptissue away from the vapor outlets of the vapor delivery component. Thedistal ends 26 and 28 of basket 18 are disposed in the os 30 and 32 ofthe Fallopian tubes 34 and 36 to orient the device within the cavity andto help seal the Fallopian tube os. The basket struts 56 and 58 conformto any irregularities in the uterine wall as shown in FIG. 3.

Vapor (such as steam) is produced in a handle portion 38 of vapordelivery component 16 or produced remotely by a vapor generatorconnected via a conduit, and introduced into the uterine cavity throughports 40 in the distal end of the vapor delivery component. Water may besupplied to handle 40 via water line 44. The steam within the uterinecavity is shown at 42. Further details of suitable vapor generationparameters and equipment may be found in US 2004/0068306.

FIGS. 6 and 7 show alternative shapes for vapor delivery component ports40. In FIG. 6, ports 40 are round. In FIG. 7, ports 40 are slots.

FIGS. 8 and 9 show another alternative design for the distal end ofvapor delivery component 16. In addition to tear-shaped ports 40, anadditional port 46 is formed in the distal tip of vapor deliverycomponent 16. In the embodiment shown in FIG. 8A, a ball 48 is heldwithin the distal end of vapor delivery component 16 just proximal toport 46 by a circumferential ridge 50. As vapor pressure builds withinvapor delivery component 16, divots 49 in ball 48 cause it to rotatewithin the chamber between port 46 and ridge 50 as the pressure escapesaround the partially occlusive sphere, thereby effectively closing andopening access to port 46. This motion creates puffs of vapor 52 throughport 46 when ball 48 is not blocking port 46 and directs more vapor 54out through side ports 40 when ball 48 is blocking port 46. In theembodiment shown in FIG. 8B, the movable component is a spiral wrappedelongated element 51, also held in place by ridge 50. By using afloating semi-occlusive element to raise the back-pressure at the tip ofthe vapor delivery component, the lumen of vapor delivery component 16may be made larger. A larger size lumen has the advantage of reducingthe amount of condensation along the course of the lumen. The amount ofresistance is a function of the fit of the semi-occlusive device to theinner lumen, the amount of decrease in the ID at the ridge 50, and thepresence, number and size of any fenestrations proximal to the ridge 50.

FIGS. 10-19 show details of the expansion mechanism and access toolcomponents of a device according to one embodiment of the invention. Theexpansion mechanism includes a basket 18 which has two deformable arms56 and 58 made, e.g., out of shape memory material. A two part plastichub 60 secures the proximal ends of the basket arms and interfaces withthe inner diameter of the introducer. The distal hub component 64 haskeyed slots that accommodate the distal ends of the wire shafts of thebasket component that allow for securing the shafts to the hub assemblylocking the shafts into the keyed slots. The proximal hub component isfabricated so that it secures the shaft within the keyed slots of thedistal hub component locking them in place as it is glued to the matedportion of the distal component. Lumens 66 and 68 in the first andsecond parts 62 and 64 of hub 60 provide access for the vapor deliverycomponent.

FIGS. 16-20 show how the basket is loaded and delivered. In theembodiment shown in FIGS. 16-19, this can be done as is done in othermedical device technologies as shown in FIGS. 17 and 18, where basketarms 56 and 58 are pulled proximally through a funnel 70 into a capturecylinder 72, and the funnel 70 is then removed. As the basket arms andcapture cylinder are advanced distally through the introducer, anexterior shoulder 74 on cylinder engages a stop 92 (shown in FIG. 31)formed on the interior of the introducer just proximal to the distal endof the introducer, guides the advancement of the basket arms 56 and 58continue to move distally. This permits arms 56 and 58 to exit thecapture cylinder and expand into the uterine cavity. In the embodimentshown in FIGS. 20A and B, a metal collar 71 with a tapered inner surface73 serves to guide the basket arms into the capture cylinder. The metalcollar 71 may thereafter be left in place or removed.

FIGS. 21-37 show further details of the access tool or introducer.Access tool 20 has a central lumen 76 extending from an inlet 78 througha shaft 80. As shown in the cross-sectional view of FIG. 25, lumen 76may be non-radially symmetrical in cross-section and may be formed withalignment features, such as ridges 82. The cross-sectional shape oflumen 76 and the alignment features 82 can help orient the basket arms56 and 58 and the vapor delivery component 20 within the lumen, as shownin FIG. 28. The lumen's cross-sectional shape and alignment features mayalso help orient and hold an obturator 84 within the lumen 76, as shownin FIG. 27, which is placed during the introduction of the introducer atthe time of the initial insertion of the device into the uterine cavity,prior to the insertion of the hysteroscope prior to the introduction ofthe vapor delivery component. The obturator serves to seal the distalend of the introducer as it passes through the cervix into the body ofthe uterus. The shaft 80 may be formed with a non-circular outercross-sectional shape, as shown in FIG. 29, to help the user orient thedevice to the plane of the uterus and to decrease the outer diameteralong one axis of the shaft.

In some embodiments it may be important to minimize heat transfer to thecervical canal. As shown in FIGS. 28 and 29, the shaft of the vapordelivery component 16 is held away from the walls of the introducer bythe basket arms 56 and 58 and by the alignment features 82. In someembodiments, the introducer shaft provides additional heat protectionthrough active cooling by circulating cooling fluid around the outsideof the vapor delivery component. For example, cooling fluid (such assaline) may be introduced through an inlet port 86 at the inlet of theintroducer and into lumens 88 and 90 extending through the introducershaft 80, as shown in FIGS. 30 and 31. Lumens 88 and 90 terminateproximal to the distal end of introducer shaft 80. Cooling fluid flowingout of the distal ends of lumens 88 and 90 is pushed proximally by thepressure of the vapor within the uterine cavity and flows proximallywithin lumen 76 around the exterior of vapor delivery component 16 andthe basket arms (not shown in FIG. 31).

The interior introducer shaft 80 may be provided with ridges or spokes92 to hold the vapor delivery component 16 in the center and to providespace for the basket arms 56 and 58, as shown in FIGS. 32-34. In theseembodiments, introducer shaft 80 may be formed from a polyamide.

FIGS. 35-37 show an embodiment with an additional or alternative activecooling feature. A cooling jacket 94 is disposed around the outside ofthe introducer shaft. After insertion of the introducer, basket arms andthe vapor delivery component into the uterus, cooling fluid mayintroduced into cooling jacket 94 through an inlet 96. This additionalcooling will help maintain the temperature of the cervical canal withina safe range. An optional additional feature is a sealing balloon 98around the outside of the introducer proximal to its distal end. Balloon98 may be inflated with fluid from an inlet port 100 to seal the uterinecavity prior to introduction of vapor through vapor delivery component,as shown in FIG. 37.

FIGS. 38 and 39 show an embodiment in which the sealing balloon 98 isfashioned so that in the inflated state it distends beyond the distalend of the introducer shaft or cannula 80 and (as in FIG. 39) sealsaround the vapor delivery component 16 to occlude the fluid coolingchannels of the cannula 80.

In FIG. 40, an outer water jacket 101 (e.g., a balloon or compressibleconduit, such as a PET PTCA balloon with an inner delivery componentversus a guide lumen as in a PTCA balloon) wraps around delivery cannula80. Jacket 101 surrounds the introducer in one continuous sheath or,alternatively, wraps around the introducer component spiraling from theproximal end, where the coolant inlet 96 is connected to a pressurizedcold water supply. Coolant communicates with a small fenestration 102 atthe distal end of the introducer that allows the coolant to leave thejacket 101 and enter the central lumen of the introducer, then travelback down the inside of the introducer lumen. When combined with theoccluding distal balloon 98, this active cooling arrangement creates acircuit where there is continuous coolant flow from the outercompressible conduit to the inner cooling chamber. The flow is afunction of the inlet pressure of the coolant and the size of thefenestration in the introducer that provides resistance to thepressurized coolant before allowing it to flow into the central chamber.The coolant source can be, e.g., a transfusion pressure bag or an IV bagas used in blood transfusions. The coolant pressurizes the outer conduitso that it inflates over the tissue interface, thereby separating thetissues being protected from the thermal source with a flowing coolantcomponent.

An alternative active cooling arrangement is to have the return of thecoolant travel within a second compressible spiraling conduit runningalong side of the first conduit like a candy cane where one helicalstripe flows in one direction proximal to distal and the other helicalstripe flows distal to proximal. These conduits communicate at thedistal end to complete the return path rerouting the coolant back downthe shaft on the outside of the shaft instead of via the inner lumen.There could also be a temperature feedback mechanism within the conduitso that flow can be increased in response to a rise in temperature.

FIGS. 41-42 show an embodiment in which the vapor delivery component 16has an inner lumen 108 surrounded by an outer, sealed lumen 104. Innerlumen 108 is held away from the walls of outer lumen 104 by spacers 106.A vacuum may be formed in outer lumen 108 to insulate the inner lumen.

FIG. 43 shows an embodiment in which the delivery cannula 80 has aplurality of longitudinal spokes or spacers 110 projecting radiallyinward and holding the vapor delivery component 16 (or other device)centered within the lumen. Coolant may flow through channels 112. Spokes110 may have sharp tips to reduce the mass coming into contact with thehot vapor delivery component. The remainder of each spoke serves as aheat exchanger to transfer heat from the spoke tip to the coolant.

FIGS. 44 and 45 show a modification to the FIG. 43 embodiment in whichthe spokes 110 are scalloped to further reduce the points of contactbetween the vapor delivery component 16 and the delivery cannulamaterial. The scalloping also increases the contact between the flowingcoolant and the hot vapor delivery component.

FIGS. 46-52 show yet another embodiment of a uterine heat therapy system200. The main components of system 200 are a uterine access tool 202, avapor probe 204 and a vapor source or generator (not shown). Access tool202 has a handle 206 with an access cannula 208 extending distally fromthe distal end 207 of the handle 206. A sealing balloon 210 surroundsthe distal portion of the cannula 208 and extends proximally to anindicator balloon segment 212. The distal end 201 of cannula 208 may beblunt or rounded to serve as an obturator during insertion of the accesstool into a patient's uterus.

In this embodiment, the distal portion 213 of the balloon has a uniformdiameter, and an optional intermediate stepped portion 214 is formed inthe balloon. In alternative embodiments, the stepped portion may beeliminated, and/or an increased diameter balloon portion may be formedat the distal end of the balloon. In addition, the indicator portion mayoptionally be a separate member in alternative embodiments. The balloon210 is shown in its inflated state in FIGS. 46 and 47. During insertioninto the uterus, the balloon will be in a flattened or deflated state tolower the access tool's insertion profile.

As in earlier embodiments, access tool 202 has an expansion mechanismfor moving uterine tissue apart and away from the tool. In thisembodiment, the expansion mechanism has two flexible arms 216 and 218formed, e.g., from shape memory material. Arms 216 and 218 are integralwith or connected to wires or rods extending proximally through accesstool 202 along or within cannula 208 to an actuator 220 on handle 206.In this embodiment, the wires extending proximally from arms 216 and 218are disposed in lumens 217 and 219 formed in cannula 208. The lumens 217and 219 are shown in FIGS. 49 and 50, which omit the wires for clarity.

Actuator 220 may be operated to advance or withdraw arms 216 and 218,which are shown in their advanced state in FIGS. 47 and 48. In thisadvanced stated within a uterus, arms 216 and 218 move uterine tissueaway from the distal end of access tool 202. Unlike earlier embodiments,however, arms 216 and 218 extend only partway up the uterine wall and donot reach or occlude either fallopian tube os. When withdrawn, arms 216and 218 collapse and are pulled into a chamber 203 formed in the distalportion of cannula 208.

As shown in more detail in FIGS. 48-50, cannula 208 has a plurality oflumens. A central access lumen 222 communicates at its proximal end witha port 224 in a Tuohy-Borst clamp 226. At its distal end, lumen 222extends to the distal end of the cannula and into the uterus when theaccess tool is placed in the uterus. A port at the distal end of lumen222 and in the proximal portion of chamber 203 is disposed between thearms 216 and 218 of the expansion mechanism.

A plurality of inlet and outlet ports are formed in handle 206. Acoolant inlet port 228 connects to a coolant inlet line 230; a coolantoutlet port 232 connects to a coolant outlet line 234; a saline flushinlet port 236 connects to a saline inlet line 238; and a saline outletport 240 connects to a saline outlet line 242. In this embodiment, theinlet and outlet lines combine into an optional single flexible hose244. Hose 244 connects to sources of coolant and saline flush solution(not shown) via a connector 246.

As shown in FIGS. 48-50, coolant entering handle 206 through port 228enters cannula lumen 250 via an opening 248 formed in the proximal endof cannula 208 within handle 206. A port 252 formed in a distal portionof lumen 250 allows coolant to exit the lumen and enter the interior ofballoon 210. The pressurized coolant flows proximally within balloon 210and enters a return lumen 254 through a port 256 located within theindicator portion 212 of the balloon. The returning coolant exits lumen254 via an opening 258 in the handle and then enters coolant return line234 through port 232. This flow path is shown by arrows in FIG. 48.

In a similar manner, pressurized saline may be introduced through inletline 238 and port 236 which communicates with lumen 222 via an opening(not shown) within handle 206 so that the uterus can be flushed withsaline. Returning saline from the uterus enters a lumen 260 in cannula208, then flows back through an opening (not shown) within handle 206,then through port 240 into return line 242.

Cannula 208 may be formed with optional longitudinal grooves 262 toprovide a return flow path for the coolant through the balloon, even ifthe patient's anatomy does not permit the balloon to inflate in anysubstantial way.

FIG. 51 shows an optional mesh or net 264 covering at least a distalportion of balloon 210 to constrain expansion of that portion of theballoon. Also in FIG. 51, the expansion mechanism actuator 220 has beenmoved to draw the expansion arms into the distal end of the access tool.

Vapor probe 204 connects to a vapor source (not shown), such as a boileror other steam generator, via an insulated flexible hose 270 andconnector 246. A vapor delivery cannula 272 extending from a handle 273has a central vapor delivery lumen 274 and a concentric annular vaporreturn lumen 276 surrounding lumen 274, as shown in FIG. 52. Wheninserted through port 224 into lumen 222 of the access cannula 208, thedistal end 280 of vapor delivery cannula 272 extends beyond the distalend of cannula 208 to a position between expansion arms 216 and 218 whenthe arms are in their advanced position, as shown in FIG. 47.

When connected to a vapor source, vapor flows through a vapor supplylumen (not shown) in hose 270 into handle 273 through a lumen 282 into achamber 284. When valve 286 is in its closed position, all vaporentering chamber 284 flows through a lumen 288 back into a vapor exhaustlumen (not shown) in hose 270 to a vapor and/or condensate collectionvessel (not shown). This flow of vapor within the handle portion of thevapor probe provides a warming circuit for the vapor probe to helpensure that the vapor quality will be maintained at its appropriatelevel when the valve is opened and vapor is delivered to the patient.

When valve 286 is opened, at least a portion of the vapor flows throughvalve 286 into lumen 274 of vapor cannula 272 and out the distal end ofthe vapor cannula for providing uterine heat therapy. Returning vaporand/or condensate flows proximally through annular lumen 276 into avapor return lumen 290 in handle 273, then through an opening 292 intolumen 288 and the vapor exhaust lumen in hose 270. Vapor flow is shownby arrows in FIG. 52.

In one embodiment, only a portion of the vapor supplied to chamber 284of the vapor probe flows into vapor delivery cannula 272 when valve 286is open. In this embodiment, most of the vapor returns through lumen 288to hose 270. Vapor flowing in lumen 288 past the opening 292 of vaporreturn lumen provides a venturi action that helps pull the exhaust vaporand any condensate through lumen 290 and annular lumen 276.

A thermocouple (not shown) may be disposed at the distal end of thevapor delivery cannula 272 and connected to a monitor or controller (notshown) to monitor intrauterine temperature and provide a signal to avapor delivery controller for controlling the therapy.

When using the system of the invention to provide uterine heat therapyto a patient to treat, e.g., endometriosis, access to the uterus isobtained by inserting a speculum into the patient's vagina and graspingthe cervix with a tenaculum. The tenaculum pulls the cervix forwardwhile the speculum pushes down on the patient's peritoneum to straightenthe uterine canal and align it with the vaginal canal. If desired, ahysteroscope may be inserted through port 224 of the access tool withthe distal end of the hysteroscope at the level of the obturator tip 201of the access tool, and the Tuohy-Borst seal may be tightened around thehysteroscope. The access tool cannula may then be lubricated andinserted through the cervix. The flexibility of the access tool(including the flexible cannula 208 and flexible expansion arms 216 and218) permits insertion with a minimum of straightening of the cervicalcanal. In addition, the blunt obturator tip 201 of the access cannula208 helps minimize the likelihood of perforation as the access tool isadvanced.

Once the distal end of the access cannula 208 has passed through theinternal cervical os into the uterine cavity, the hysteroscope can beused to confirm placement. The hysteroscope may be advanced beyond thedistal end of the access cannula 208, if desired. After confirmingposition of the access cannula, the expansion arms 216 and 218 areadvanced by pushing actuator 220 forward. This action engages arms 216and 218 with the uterine wall tissue to move the tissue away from thedistal end of the vapor probe.

The coolant balloon 210 may then be inflated by providing pressurizedcoolant through the coolant inlet, as described above. Balloon 210expands to seal the cervical canal up to the internal cervical os. Asthe balloon engages the cervical canal wall, coolant pressure willcontinue to rise up toward the coolant inlet pressure. When the pressureof coolant within the balloon reaches an indicator pressure, theindicator portion 212 of the balloon will expand to provide anindication to the user that the distal portion of the balloon hasengaged the wall of the cervical canal to seal the opening. If ahysteroscope was used, it can now be removed.

The vapor delivery cannula 272 of vapor probe 204 is then insertedthrough port 224 until the distal tip 280 extends through the distal endof the access cannula 208, as shown in FIG. 47. Hose 270 may beconnected to the vapor source prior to or while the access tool is beinginserted into the patient so that the warming circuit can warm the vaporprobe handle and internal components. When ready to deliver therapy tothe patient, valve 286 is opened to permit vapor to flow through vapordelivery cannula 272 into the patient's uterus.

In one embodiment, a thermocouple disposed at the distal end of thevapor delivery cannula monitors intrauterine temperature. Thethermocouple provides a temperature signal to a vapor deliverycontroller to initiate a timed sequence once the uterine cavity reachesa threshold temperature, such as 50° C. The controller discontinuesvapor flow after the predetermined time.

After completion of the vapor therapy, the expansion arms are retractedand coolant flow is stopped. After the indicator balloon segmentdeflates, the access tool and vapor delivery probe may be removed fromthe patient.

In some embodiments of the method, a saline flush may be provided priorto the procedure and/or at the end of the procedure. As described above,saline may be provided through lumen 222 around the hysteroscope orvapor delivery probe. Delivering saline at the end of the procedure maybe desirable to release any vacuum formed in the uterus due tocondensation of vapor.

Vapor may be delivered to the uterus at an intrauterine pressure of 5 to35 mm Hg. Coolant pressure within the sealing balloon may be 50 to 300mm Hg. Typical therapy time for treating endometrial tissue may rangefrom 15 sec. to 120 sec., with a preferred duration of 45-60 sec.

FIGS. 53-55 show another embodiment of the uterine heat therapy systemof this invention. In this embodiment, the distal end of an expansionmechanism 302 extends beyond the distal end of a uterine access toolcannula 304. Expansion mechanism 302 has two blunt distal ends 306 and308 each of which has aproximally facing shoulder 310 and 312,respectively. Shoulders 310 and 312 rest on the distal end 316 ofcannula 304 when the expansion mechanism is in its undeployed position,as shown in FIG. 53B.

A central fenestration channel is formed by the cooperation of two halfchannels 318 and 320 formed on cooperating interior surfaces 319 and 321of expansion mechanism ends 306 and 308 to provide an opening throughthe expansion mechanism, even in its undeployed position, to permitaccess through the expansion mechanism by a hysteroscope or probe 322 asshown in FIG. 53A. The channel may be used to permit visualization by ahysteroscope during advancement of the access tool into the uterus.

Actuation wires or rods 324 extend proximally from the distal ends ofthe expansion mechanism through an interior lumen 326 of the cannula toan actuator (not shown). Other lumens 328 may be formed in cannula 304for coolant flow, saline flush, etc. as described in earlierembodiments.

When the expansion mechanism is actuated, the distal ends 306 and 308move distally. As the ends 306 and 308 move distally, camming surface330 on distal end 306 and camming surface 332 on distal end 308 slideagainst the hysteroscope (or other inserted component) 322, and cammingsurface 334 on distal end 306 and camming surface 336 on distal end 308slide against the distal end of cannula 304 to cause the distal ends 306and 308 to move apart, thereby engaging and moving uterine tissue awayfrom the distal end of the inserted tool 322, as shown in FIG. 54.Further distal advancement of the expansion mechanism causes the distalends 306 and 308 to move further apart due to a pre-bent shape of thewires or rods 324, as shown in FIG. 55.

FIG. 56 shows aspects of a uterine therapy system 400 according to yetanother embodiment of the invention. In this embodiment, the distal end408 of the vapor delivery probe 412 extends beyond the distal end 404 ofthe uterine access tool cannula 402. During therapy, vapor is deliveredfrom the distal end of the vapor delivery probe 412, and vapor and/orcondensate is returned through the annular space in the cannulasurrounding the vapor delivery probe.

An atraumatic tip 414 is supported distal to the distal end of the vapordelivery probe by a coil 410. Coil 410 may be attached to the probe 412by, e.g. welding. During vapor delivery, vapor will pass throughadjacent windings of coil 410 to reach uterine tissue.

1. A method of providing heat therapy to a patient's uterus comprising: inserting an access tool through a cervix and a cervical canal into the uterus, the access tool comprising a lumen; after inserting the access tool into the uterus, creating a seal between an exterior surface of the access tool and an interior cervical os; providing an indication to a user that the seal has been created; delivering vapor through the access tool lumen into the uterus; and condensing the vapor on tissue within the uterus.
 2. The method of claim 1 wherein the step of creating a seal comprises expanding an expandable member.
 3. The method of claim 2 wherein the expandable member comprises a balloon.
 4. The method of claim 3 wherein the expanding step comprises preferentially expanding a sealing portion of the balloon disposed at the interior cervical os prior to an indicator portion of the balloon disposed proximal to the interior cervical os.
 5. The method of claim 1 further comprising placing an expansion mechanism in contact with tissue within the uterus to move uterine tissue away from an opening in the access tool lumen.
 6. The method of claim 5 further comprising advancing the expansion mechanism distally with respect to the access tool lumen prior to the placing step.
 7. The method of claim 1 wherein the step of delivering vapor comprises inserting a vapor delivery tool through the access tool lumen.
 8. The method of claim 1 further comprising exhausting vapor and/or vapor condensate from the uterus.
 9. A method of providing heat therapy to a patient's uterus comprising: inserting an access tool through a cervix and a cervical canal into the uterus, the access tool comprising a lumen; after inserting the access tool into the uterus, expanding a balloon to create a seal between an exterior surface of the access tool and an interior cervical os, wherein expanding comprises preferentially supplying coolant to a sealing portion of the balloon disposed at the interior cervical os prior to supplying coolant to an indicator portion of the balloon disposed proximal to the interior cervical os; providing an indication to a user that the seal has been created; delivering vapor through the access tool lumen into the uterus; and condensing the vapor on tissue within the uterus. 